JCXH-213 for relapsed or refractory CD19-positive B‑cell non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional clinical trial gives JCXH-213, an mRNA‑LNP in vivo CAR therapy, to adults with relapsed or refractory CD19-positive B‑cell non‑Hodgkin lymphoma. Eligible patients have pathologically confirmed CD19-positive disease, measurable lesions per Lugano 2014, and ECOG performance status 0–1. Treatment is administered during a defined observation period, and patients may continue receiving the therapy afterwards if there are no major safety concerns and the investigator judges ongoing benefit. The study focuses on safety and tolerability as well as preliminary signals of anti-tumor activity measured by response criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cytologically or histopathologically confirmed CD19-positive B-cell Hodgkin lymphoma according to WHO 2022 criteria, including but not limited to pathologically confirmed (1) diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS); (2) follicular lymphoma (FL); (3)histologically transformed into diffuse large B-cell lymphoma; (4) primary mediastinal large B-cell lymphoma (PMBCL); (5) High-grade B-cell lymphoma (HGBCL) etc.
* ECOG performance status 0 to 1.
* Existing measurable lesions (Lugano 2014 criteria, as detailed in Appendix 2), meeting one of the following conditions: 1) nodal lesions with a long axis length exceeding 15 mm (short axis length is measurable); 2) extra-nodal lesions with both long axis and short axis lengths exceeding 10 mm.

Exclusion Criteria:

* Patients with other malignant tumors within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local radical prostatectomy, radical ductal carcinoma in situ, and radical thyroidectomy.
* B-cell non-Hodgkin lymphoma with active primary or secondary central nervous system involvement.
* Life expectancy less than 3 months.

Where it's running

• Department of Lymphoma and Myeloma, Yuhengnan Road, Changping District, Beijing
  Beijing, China Recruiting

Study contacts

• Principal investigator: Kai Hu, Chief Physician — Beijing GoBroad Hospital
• Study coordinator: Kai Hu
• Email: HK13610956245@163.com
• Phone: +86 15810245863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.